Real-world treatment patterns and outcomes of patients with unresectable or metastatic urothelial carcinoma receiving systemic therapy in Japan.

BACKGROUND

Cisplatin-based chemotherapy has traditionally been the standard treatment for unresectable or metastatic urothelial carcinoma (mUC). Recently, the longstanding paradigm has changed with the emergence of immune checkpoint inhibitors and antibody-drug conjugates, such as pembrolizumab and enfortumab vedotin (EV). This longitudinal descriptive study aimed to identify real-world treatment patterns and assess the outcomes of patients with mUC between 2010 and 2023.

METHODS

Patients with mUC who received first-line systemic therapy were identified from a Japanese electronic medical records database. A Sankey diagram was used to present the proportion of patients who transitioned to second- and third-line therapies. Kaplan-Meier survival analysis was used to estimate the time to next treatment (TTNT) and overall survival (OS).

RESULTS

A total of 794 patients were included in this study. The median age of the patients was 73.0 years, and 72.9% were male. The most common primary tumor site was the bladder (59.7%). First-line therapy comprised cisplatin-based regimens in 52.0% of the patients (11.8% at standard doses, 32.4% at reduced doses, and 7.8% at unknown doses), carboplatin-based regimens in 32.1%, and other regimens in 15.9%. Among the patients enrolled after 2017, following the approval of pembrolizumab for mUC progressing after chemotherapy in Japan, 58.2% received pembrolizumab as second-line therapy, and 19.1% received EV monotherapy as third-line therapy. The median OS for the total population was 24.1 months, with patients enrolled between 2010 and 2016 having a shorter OS (21.1 months) than those enrolled between 2017 and 2022 (24.9 months). For patients with eGFRs of ≥60 and <60 mL/min/1.73 m

CONCLUSION

Platinum-based regimens, including reduced-dose cisplatin and carboplatin, remain the predominant first-line systemic therapies. Since 2017, pembrolizumab and EV have become widespread choices for second-line and subsequent treatments, gradually surpassing the previously prevalent platinum-based regimens. The introduction of these novel therapies might have prolonged the OS of patients with mUC. A plain language summary is available in this article.

Informations de copyright

Copyright © 2024 Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, The Author(s). Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toshihiko Minegishi reports financial support was provided by MSD KK. Shingo Kojima reports financial support was provided by MSD KK. Kotoba Okuyama reports financial support was provided by MSD KK. Toshiki Fukasawa reports financial support was provided by Real World Data Co Ltd. Hidetoshi Uenaka reports financial support was provided by Real World Data Co Ltd. Mizuho Akahane reports financial support was provided by Real World Data Co Ltd. Makito Miyake reports financial support was provided by MSD KK. Shotaro Yasuoka reports financial support was provided by MSD KK. Yuichiro Ito reports financial support was provided by MSD KK. Toshihiko Minegishi reports a relationship with GSK plc that includes: equity or stocks. Toshihiko Minegishi reports a relationship with Merck & Co Inc that includes: equity or stocks. Yuichiro Ito reports a relationship with Bayer AG that includes: equity or stocks. Yuichiro Ito reports a relationship with Merck & Co Inc that includes: equity or stocks. Makito Miyake reports a relationship with Pfizer Inc that includes: consulting or advisory and speaking and lecture fees. Makito Miyake reports a relationship with Merck Biopharma Co.Ltd. that includes: speaking and lecture fees. Makito Miyake reports a relationship with Astellas Pharma Inc that includes: consulting or advisory and speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.